Thoracic Oncology Program »  Research »  Clinical Trials »  CALGB-30901

Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy

Official Title:

Randomized Phase II Study of Maintenance Pemetrexed Versus Observation for Patients With Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
Phase 2 Interventional 18 Years and older Alliance for Clinical Trials in Oncology CALGB-30901
CALGB-30901
U10CA180821
U10CA031946
CDR0000667496
NCT01085630
Ongoing but not enrolling patients

Study Design:


Principal Investigator

Professor of Medicine
Chair, Data and Safety Monitoring Committee
Bonnie J. and Anthony Addario Endowed Chair in Thoracic Oncology
UCSF Helen Diller Family Comprehensive Cancer Center

Trial Summary

RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This randomized phase II trial is studying how well pemetrexed disodium or observation works in treating patients with malignant pleural mesothelioma without progressive disease after first-line chemotherapy.

Eligibility

Inclusion Criteria:
  • Histologically confirmed malignant pleural mesothelioma meeting 1 of the following
    cell types:
        - Epithelial
        - Sarcomatoid
        - Mixed type
              - Histologically documented malignant pleural mesothelioma, epithelial,
                 sarcomatoid or mixed type, not amenable to surgical resection
              - Prior treatment
  • Currently receiving first-line treatment with pemetrexed + platinum; patients are to
    be registered to Cancer and Leukemia Group B (CALGB) 30901 no later than the last day
    of cycle 4 of first line therapy
  • Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) are
    acceptable; prior intrapleural cytotoxic chemotherapy will not be considered systemic
    chemotherapy
  • Prior surgical treatment is allowed
  • Prior radiation therapy is allowed
        - Non-pregnant and non-nursing; women of child bearing potential and men must
           agree to use an appropriate method of birth control throughout their
           participation in this study; appropriate methods of birth control include
           abstinence, oral contraceptives, implantable hormonal contraceptives (Norplant),
           or double barrier methods (diaphragm plus condom)
        - RANDOMIZATION ELIGIBILITY CRITERIA
        - Patients with complete response, partial response, or stable disease following
           4, 5 or 6 cycles of first-line chemotherapy with pemetrexed AND either cisplatin
           or carboplatin; a maximum of 6 cycles of chemotherapy may have been given
        - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
        - Granulocytes >= 1,500/ul
        - Platelet count >= 100,000/ul
        - Total bilirubin =< 1.5 x upper limit of normal (ULN)
        - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
           [SGOT]) =< 2 x ULN
        - Calculated creatinine clearance >= 45 ml/min
  • Disease not amenable to surgery
  • Must be enrolled on imaging protocol CALGB-580903
  • Complete response, partial response, or stable disease after completion of 4 courses
    of first-line chemotherapy comprising pemetrexed disodium AND cisplatin or
    carboplatin
        - Study therapy will begin within 9 weeks following day 1 of cycle 4 of first-line
           treatment
  • No clinically significant pleural or peritoneal effusions that cannot be adequately
    managed by drainage before or during pemetrexed disodium
PATIENT CHARACTERISTICS:
  • ECOG performance status of 0-1
  • Life expectancy ≥ 12 weeks
  • Granulocytes ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 2 times ULN
  • Creatinine clearance ≥ 45 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No psychiatric illness that would prevent the patient from giving informed consent
  • No second malignancy except non-melanoma skin cancer or carcinoma in situ of the
    cervix unless curatively treated with no evidence of active disease for ≥ 5 years
  • No medical conditions that, in the opinion of the treating physician, would make
    study treatment unreasonably hazardous for the patient including, but not limited to,
    the following:
        - Ongoing or active infection such as HIV positivity
        - Inability to take oral medications
        - Psychiatric illness/social situations that would limit compliance with study
           requirements
PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) allowed
        - Prior intrapleural cytotoxic chemotherapy not considered systemic chemotherapy
  • Prior surgery allowed
  • Prior radiotherapy allowed
        - No concurrent palliative radiotherapy
  • No concurrent hormones or other chemotherapeutic agents except for the following:
        - Steroids for adrenal failure
        - Hormones for nondisease-related conditions (e.g., insulin for diabetes)
        - Intermittent use of dexamethasone as an antiemetic or premedication for
           pemetrexed disodium

Detailed Description

OBJECTIVES:
Primary
  • To determine if maintenance therapy with pemetrexed disodium versus observation
    improves progression-free survival of patients with malignant pleural mesothelioma who
    have at least stable disease after completion of first-line therapy comprising
    pemetrexed disodium with cisplatin or carboplatin.
Secondary
  • To determine the overall survival of patients treated with this regimen versus
    observation.
  • To evaluate the frequency of responses in patients treated with this regimen.
  • To assess the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to first-line
chemotherapy regimen (cisplatin/pemetrexed disodium vs carboplatin/pemetrexed disodium),
histologic subtype (epithelioid vs other) and number of courses received (< 6 vs 6).
  • Arm I: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Treatment
    repeats every 21 days in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients undergo observation until disease progression. After completion of
    study therapy, patients are followed up every 6 months for 3 years.

Important

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 1/26/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
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